IOM: U.S. Drug Errors Harm 1.5 Million Annually

Medication errors harm at least 1.5 million patients every year in hospitals, long-term-care facilities, and outpatient clinics, resulting in billions of dollars in extra medical costs, the Institute of Medicine (IOM) said in a report issued today.

At least a quarter of medication-related injuries are preventable, panelists asserted, noting that not all medication errors result in injury.

"The current process by which medications are prescribed, dispensed, administered, and monitored is characterized by many serious problems that threaten both the safety and positive outcomes of patients," committee cochair J. Lyle Bootman, dean of the College of Pharmacy at University of Arizona in Tucson, said today during a media briefing.

Medication errors in hospitals occur most frequently at the prescribing and administration stages, IOM found.

Estimating costs of medication errors is difficult since most of what is known relates to the additional costs of treating patients who have been injured.

IOM estimated that the extra medical costs of treating drug-related injuries in hospitals is $3.5 billion a year, based on a "conservative" figure of about 400,000 preventable adverse drug events (ADEs) per year.

However, IOM said, there is no estimate of the associated health care costs of preventable ADEs for those facilities.

The best estimate panelists were able to make about ambulatory care facilities is based on studies of Medicare beneficiaries 65 years or older. A 2003 study found that there were about 530,000 preventable ADEs in that outpatient population. Another study projected that the extra costs of ADEs for outpatient Medicare beneficiaries totaled $887 million, or $1983 per ADE.

The data reviewed by IOM for its report excluded errors of omission—failure to prescribe medications for which there is evidence of their ability to reduce morbidity and mortality.

The studies IOM reviewed also did not take into account costs to patients, such as lost earnings, costs of not being able to carry out household duties, and compensation for pain and suffering.

In addition, panelists said, there is little data available about the costs of medication errors that do not result in harm.

"While no injury is involved, these errors often create extra work, and the costs involved may be substantial," IOM stated.

Congress in the Medicare Modernization Act of 2003 ordered the IOM study, which was funded by the Centers for Medicare and Medicaid Services, to formulate a national agenda for reducing medication errors.

IOM was charged with developing estimates of the incidence of medication errors and determining the efficacy of prevention strategies.

The committee recommended a series of actions for patients, health care organizations, government agencies, and pharmaceutical firms.

"Safe and effective use of medications requires that everyone do their part, from the patient right up to regulators and everyone in between, which is why the report contains recommendations for each of those parties in the whole chain of medication use," said IOM panelist Albert W. Wu, professor of health policy and management and internal medicine at Johns Hopkins University in Baltimore.

The "most powerful" strategy for improving safety and achieving desired clinical results, Bootman said, "may be motivating providers and organizations to support the full engagement of patients and their guardian in improving the safety and effectiveness of medication use."

By becoming more informed and engaged, IOM stated, consumers may decrease the probability of experiencing a medication error.

"The patient is a very critical component," Bootman said. "There are many avenues for error at the patient level. That's why in this report, right up front, we specify that the patient needs to be heavily engaged in this process communicating with providers and those of us who participate in the process."

Patients should ask questions and insist on answers from their health care providers and make sure that prescribers clearly and fully explain the patient's medication regimen, the committee said.

Wu also suggested that patients have their physicians clearly write instructions about how to take their medications.

"All of these things may wind up being a little bit of an annoyance to providers, but we'll get used to it," he said.

If a patient is uncomfortable about personally being able to manage their medications, said panelist Wilson D. Pace, professor of family medicine at the University of Colorado in Denver, the person should seek a surrogate who can communicate with health care providers on behalf of the patient.

Patients should keep an up-to-date list of their medications and review the list with their providers during office visits, the committee suggested.

The reconciliation process can be expedited when medication data are transmitted electronically among providers, with confirmation by the patient, panelists stated.

Study results examining the use of information technology in reducing medication errors have been promising, Bootman said.

Health care organizations, IOM counseled, should adopt technology that enables practitioners to have access to comprehensive reference information concerning medications and related health data, communicate patient-specific medication-related information in an interoperable format, and assess the safety of medication use through active monitoring.

All providers by 2010 should be using electronic prescribing systems and all pharmacies should be able to receive prescriptions electronically, panelists insisted.

"Studies indicate that paper-based prescribing is associated with high error rates," Bootman said. "Electronic prescribing is safer because it eliminates problems with handwriting legibility and, when combined with decision-support tools, automatically alerts prescribers to possible interactions, allergies, and other potential problems."

Other recommendations the panel made included having regulators work closely with the drug industry to avoid giving medications names similar to other products on the market—look-alike, sound-alike names—and to develop information for prescribers and consumers that is easily understood.

In a statement issued today, FDA said it had partnered with the Institute on Safe Medication Practices to "refine" its review of look-alike, sound-alike drug names, and "will continue to evaluate our process before a drug is approved in which a proposed drug name along with its labels and labeling are evaluated for their potential to cause medication errors."

Regulators also this week issued guidance to developers of consumer medication information to ensure leaflets patients receive with their prescriptions contain useful information. In January, the agency added, regulators announced new requirements that revise the content and format of prescribing information on drug and biological products to make it easier for prescribers to access, read, and use the information.